MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERITONEAL; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8888111132

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the catheter had been placed.The insertion site was treated with chloraprep and loban prior to placement.At the post op visit, the insertion and exit sites were noted to have erythema and purulent drainage.The patient was started on oral bactrim and the catheter was scheduled for removal.It was stated that intraoperative, there was no purulent drainage in the abdominal cavity, so the exit site of the catheter was changed and the external portion of the catheter was changed as well.

• Brand Name: PERITONEAL
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: jacqueline st. pierre ; 15 hampshire st.; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7421008
• MDR Text Key: 105120494
• Report Number: 3009211636-2018-00117
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521196087
• UDI-Public: 10884521196087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888111132
• Device Catalogue Number: 8888111132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR